Clinical Trials

Inclusion Criteria:

• Age ≥ 18 years.
• Symptomatic New York Heart Association (NYHA) class II-IV.
• Moderate-to-severe or severe MR (3+) despite optimal guidelinedirected medical therapy (GDMT) as determined by an independent Echo Core Lab.
• Unsuitable for MV surgery and TEER as determined by the site Heart Team.

Exclusion Criteria:

• Inability to understand the trial or a history of non-compliance with medical advice. Note: this includes subjects with previous or current drug or alcohol abuse.
• Inability to provide signed Informed Consent Form (ICF).
• History of any cognitive or mental health status that would interfere with participation in the trial.
• Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)).
• Female subjects who are pregnant or planning to become pregnant within the trial period.
• Unable to comply with follow-up schedule and assessments including inability to complete assessments (e.g., 6MWT).
• Known hypersensitivity or contraindication to heparin or warfarin without adequate alternative medications.
• Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
• Known hypersensitivity to contrast media that cannot be adequately medicated.
• Need for emergent or urgent surgery.
• Subjects who have been placed in an institution on the basis of an official or judicial order.

Exclusion Criteria Related to Previous or Planned Interventions

• Aortic repair or replacement:
  • Aortic valve/root transcatheter repair or replacement within 90 days prior to the index procedure.
  • Aortic valve/root surgical repair or replacement within 6 months prior to the index procedure.
• Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.
• Previous heart transplant.
• Planned cardiovascular intervention within 30 days post index procedure.

Exclusion Criteria Related to Comorbidities

• History of a stroke or transient ischemic attack (TIA) within 90 days prior to the index procedure.
• Severe chronic obstructive pulmonary disease (COPD) or interstitial lung disease requiring home O2.
• Active peptic ulcer or upper GI bleeding within 90 days prior to the index procedure.
• History of bleeding diathesis, coagulopathy or intention to refuse blood transfusion if one should become necessary.
• Concurrent medical condition with a life expectancy of less than 12 months.
• Leukopenia (white blood cells < 3500 cells/µL).
• Thrombocytopenia (platelets < 90 x103 /µL).
• Anemia (hemoglobin < 8g/dl or > 4g/dl drop from baseline).
• Moderate or severe neutropenia (absolute neutrophil count < 1000 cells/µL).
• Renal insufficiency with eGFR < 30 or end stage renal disease requiring renal replacement therapy.
• Liver failure.
• Evidence of active infection on the day of the index procedure.
• History of amyloidosis.
• History of Hodgkin’s disease.
• Active cancer (except cancer that is low grade, maintained or inremission such as chronic lymphocytic leukemia) or history of cancer requiring radiation treatment to the mediastinum. Exclusion Criteria Related to Cardiovascular Function.

Exclusion Criteria Related to Cardiovascular Function

• Intracardiac mass, thrombus, or vegetation.
• Active endocarditis or completed treatment for endocarditis within the last 6 months.
• Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.
• Left ventricular end-diastolic diameter (LVEDD) ≥ 70mm.
• Clinically significant coronary artery disease (CAD) requiring intervention.
• Left atrial appendage (LAA) occlusion device within 6 months prior to the index procedure.
• Need for aortic valve, tricuspid valve or pulmonary valve intervention.
• Significant pulmonary hypertension with pulmonary artery systolic pressure (PASP) > 70mmHg (as determined by right heart catheterization (RHC)).
• Hemodynamic instability (e.g., requiring pressors, intra-aortic balloon pump (IABP), etc.).
• Severe right ventricular (RV) dysfunction, defined as:
  • TAPSE < 1.3
  • Fractional area chance (FAC) < 25% c. RVS’ < 10cm/sec.
• Severe carotid stenosis.
• Untreated severe tricuspid valve disease.
• Untreated severe aortic valve disease.
• Significant mitral stenosis.
• Presence of a device that is anticipated to interfere with implant (e.g., previously placed TEER).

Anatomical Exclusion Criteria

• Anatomic contraindication:
  • Dimensions of left atrium (LA) that are outside of AltaValve sizing criteria.
  • Dimensions of MV annulus that are outside of AltaValve sizing criteria.
  • Significant elliptical LA ratio.
  • Significant elliptical MV annulus ratio.
  • Significant volumetric changes of LA.
  • Significant small dimensions of left ventricle (LV).
  • Anatomically prohibitive MAC.
  • Significant LA tilt angle.
  • Inadequate steering angle.
  • Significant LA height or width changes from baseline to procedure (i.e., greater than or equal to 8mm from baseline to index procedure as measured by TTE).
  • Inadequate TS puncture height (i.e., < 30mm or > 60mm)
  • Others (to be recorded via electronic case report form (eCRF)).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/05/2024. Questions regarding updates should be directed to the study team contact.